Research published in the American Journal of Psychiatry has prompted the Food and Drug Administration (FDA) to conduct an ongoing safety review of the stimulant drugs used to treat attention deficit-hyperactivity disorder (ADHD) in children. The researchers used a matched case-control design to compare the use of stimulant drugs in 564 healthy children who died suddenly (some of unknown cause, some of cardiac arrhythmia) with their use in 564 healthy children who died in automobile accidents. The drugs assessed included dextroamphetamine (Dexedrine, DextroStat, and others), methamphetamine (Desoxyn), and methylphenidate (Concerta, Ritalin, and others). (Adderall, a combination of amphetamine aspartate, amphetamine sulfate, dextroamphetamine sulfate, and dextroamphetamine saccharate, hadn't yet been approved to treat ADHD when the study was conducted.)

Gould and colleagues assessed mortality data on U.S. children ages seven to 19 who died between 1985 and 1996. Parents were asked to complete a survey on the children's medical history, the medications taken at the time of death, and the use of over-the-counter and prescription drugs. Medical examiner reports and toxicology findings were also reviewed, but the children's psychiatric status (including clinical diagnosis of ADHD) was not included because the data were incomplete. Ten (1.8%) of the healthy children who died suddenly were taking stimulant drugs, compared with only two (0.4%) of the children who died in automobile accidents. The authors found a significant association between sudden death in healthy children and the use of stimulant medication, especially methylphenidate, although limitations in the study methodology prevented a definitive conclusion.

Given these limitations, the FDA doesn't recommend that parents or health care providers stop a child's stimulant medication on the basis of the present findings. Health care providers are urged to follow the current recommendations for prescribing stimulant drugs-assessment for a history of cardiovascular disease in the child and family, a focus on the cardiovascular system during the physical examination, and obtaining an electrocardiogram and an echocardiogram if a risk or the presence of heart disease is suspected. The FDA will continue to review current and future data on the subject and is sponsoring a large epidemiologic study, expected to be completed this year, that will provide further information about the possible risks associated with stimulant medication use in children. Although the risk of using stimulant medication in children hasn't been determined, any child who develops symptoms of cardiovascular problems (such as chest pain, shortness of breath, or fainting) should be taken to the ED immediately. See http://bit.ly/2VeZq for more information.